Pre-eclampsiaBIODOP-T1NCT01348711
Early Placental Insufficiency Screening
An observational study of Pre-eclampsia, run by University Hospital, Tours at 4 sites in France.
Trial summary
To assess the role of uterine artery and maternal serum PlGf and sflt-1 and their combination in screening for pre-eclampsia and small -for-gestational age (SGA) fetuses at 12-14 weeks of gestation Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-eclampsia
- How many people
- 226 participants
- Where
- 4 sitesFrance
- Study dates
- May 2007to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant between 12 and 14 weeks
Who may be able to join
- Chronic hypertension under medication
- Insulin or not insulin dependant preexisting diabetes
- Previous history of pre-eclampsia
- Previous history of unexplained stillbirth
- Previous history of placental abruption
- Previous history of SGA (< 10th centile)
Show all 12Show fewer
- History of pre-eclampsia or chronic hypertension before 45 years in the mother or a sister
- History of vascular pathology before 50 years in the father
- Obesity (BMI>26)
- Nulliparous after 38 years
- Assisted conception with donor
- Primipaternity after 38 years old or before 20 years old
Who cannot join
- Multiple pregnancy
- Pregnancy requiring termination
- Unability to understand the study
- Thrombophilia
- treatment with heparin
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hospital of Blois -Service de Gynécologie-Obstétrique
Blois, 41016
CHRU Hôpital Hôtel-Dieu Département Gynécologie Obstétrique
Nantes, 44093
Hôpital La Milétrie, CHRU Poitiers
Poitiers, 86021
Olympe de Gouges Women Health Centre, Bretonneau University Hospital
Tours, 37044
About this study
Official title: Placental Insufficiency Screening During First Trimester by a Combination of Uterine Artery Dopppler, Maternal PlGF and sFLT-1 in Hight Risk Population
To assess the role of uterine artery and maternal serum PlGf and sflt-1 and their combination in screening for pre-eclampsia and small -for-gestational age (SGA) fetuses at 12-14 weeks of gestation
Read the detailed description
Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are known as major factors in perinatal morbidity and mortality. Routine antenatal care is focused on the detection of women at increased risk to apply this population a program of careful monitoring and appropriate intervention.
Uterine artery Doppler during anomaly scan at 12 to 14 weeks in selected women at increased risk, has proved to be accurate to detect those who will develop PE or IUGR during the second half of pregnancy.
A variety of angiogenic proteins have been studied as potential markers for pre-eclampsia. Among these protein Plgf and sflt-1 have respectively demonstrated higher and lower levels in pregnant women who will subsequently develop pre-eclampsia.
Our study is aimed to evaluate the performance of serum Plgf and sflt-1 measurement in association with uterine artery Doppler as a screening for placental insufficiency.
- Conditions
- Pre-eclampsia
- Keywords
- Pre-eclampsia
- Medical subject headings
- Pre-Eclampsia
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence for Pre-eclampsia or SGA
Pre-eclampsia is defined as hypertension (systolic blood pressure 140mmHg or greater or a diastolic blood pressure 90mmHg or greater on at least 2 occasions 4 hour or 1 week apart) accompanied by proteinuria (more or equal to 0.5g/day or 1 dipstick of ++ or more). SGA is defined as birth weight below the 10th centile for gestational age at birth according to the national birthweight distribution of the french population (INSERM)
Measured: During pregnancy and until 72h after delivery
Secondary outcomes (2)
Early onset pre-eclampsia
Early onset pre-eclampsia is defined as pre)eclampsia occurring before 32 completed gestational weeks.
Measured: During pregnancy and until 72h after delivery
Severe pre-eclampsia
Severe pre-eclampsia is defined as systolic blood pressure of 160mmHg or greater or a diastolic blood pressure of 110mmHg or greater and/or proteinuria greater than 5g in 24 hour collection or occurrence of abruption, eclampsia (seizures during pre-eclampsia), HELLP syndrome (hemolysis, elevated enzyme liver, low platelets), renal insufficiency, fetal demise or birth weight below the 5th centile for gestational age.
Measured: During pregnancy and until 72h after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startMay 2007
- Primary completionFeb 2011
- Study completionMay 2011
Why it stopped: Shortness inclusions of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-eclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franck PERROTIN, MD-PHD, Study director, Univsersity Hospital of TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348711
- Sponsor's protocol ID
- PHRI/06/FP-BIODOP-T1
- Acronym
- BIODOP-T1
- Status last verified
- May 2023
- First submitted
- 2 Feb 2010
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placental Insufficiency Screening During First Trimester by a Combination of Uterine Artery Dopppler, Maternal PlGF and sFLT-1 in Hight Risk Population
- ClinicalTrials.gov ID
- NCT01348711
- Acronym / sponsor ID
- BIODOP-T1 / PHRI/06/FP-BIODOP-T1
- Conditions
- Pre-eclampsia
- Keywords
- Pre-eclampsia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Shortness inclusions of patients
- Enrolment
- 226 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- May 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 5 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the role of uterine artery and maternal serum PlGf and sflt-1 and their combination in screening for pre-eclampsia and small -for-gestational age (SGA) fetuses at 12-14 weeks of gestation
Detailed description
Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are known as major factors in perinatal morbidity and mortality. Routine antenatal care is focused on the detection of women at increased risk to apply this population a program of careful monitoring and appropriate intervention.
Uterine artery Doppler during anomaly scan at 12 to 14 weeks in selected women at increased risk, has proved to be accurate to detect those who will develop PE or IUGR during the second half of pregnancy.
A variety of angiogenic proteins have been studied as potential markers for pre-eclampsia. Among these protein Plgf and sflt-1 have respectively demonstrated higher and lower levels in pregnant women who will subsequently develop pre-eclampsia.
Our study is aimed to evaluate the performance of serum Plgf and sflt-1 measurement in association with uterine artery Doppler as a screening for placental insufficiency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant between 12 and 14 weeks
Key inclusion criteria (12 listed)
- Chronic hypertension under medication
- Insulin or not insulin dependant preexisting diabetes
- Previous history of pre-eclampsia
- Previous history of unexplained stillbirth
- Previous history of placental abruption
Key exclusion criteria (5 listed)
- Multiple pregnancy
- Pregnancy requiring termination
- Unability to understand the study
- Thrombophilia
- treatment with heparin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence for Pre-eclampsia or SGA
Time frame: During pregnancy and until 72h after delivery
Pre-eclampsia is defined as hypertension (systolic blood pressure 140mmHg or greater or a diastolic blood pressure 90mmHg or greater on at least 2 occasions 4 hour or 1 week apart) accompanied by proteinuria (more or equal to 0.5g/day or 1 dipstick of ++ or more). SGA is defined as birth weight below the 10th centile for gestational age at birth according to the national birthweight distribution of the french population (INSERM)
2 secondary outcomes
Early onset pre-eclampsia
Time frame: During pregnancy and until 72h after delivery
Severe pre-eclampsia
Time frame: During pregnancy and until 72h after delivery
Results and safety
The study was stopped early (reason given: Shortness inclusions of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
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Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franck PERROTIN, MD-PHD study director
Univsersity Hospital of TOURS
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-eclampsia, run by University Hospital, Tours at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Shortness inclusions of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence for Pre-eclampsia or SGA (time frame: During pregnancy and until 72h after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.